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Diagnostic Test

Cohort 2 for Cystic Fibrosis

N/A
Recruiting
Led By Jessica Alvarez
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 year
Awards & highlights

Study Summary

The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation between DXA lean mass index and BMI
Correlation between DXA lean mass index and Short Physical Performance Battery frailty score
Correlation between DXA lean mass index and hand-grip strength
+3 more
Secondary outcome measures
Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally
Characterize BMI cross-sectionally and longitudinally
Characterize hand-grip strength cross-sectionally and longitudinally
+19 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment24 Interventions
FEV1 ≥60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation).
Group II: Cohort 1Experimental Treatment24 Interventions
Forced expiratory volume in 1 second (FEV1) <60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous glucose monitoring (CGM)
2016
Completed Phase 4
~120
Spirometry
2017
Completed Phase 2
~12540
Anthropometric Measurements
2008
N/A
~140

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor
153 Previous Clinical Trials
34,614 Total Patients Enrolled
Jessica AlvarezPrincipal InvestigatorEmory University
Melissa PutmanPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
2023. "Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639556.
~200 spots leftby Dec 2028
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